Quill TM Knotless Tissue-Closure Device
(Variable Loop Design)
Comprid of Dyed PDO (Polydioxanone)
Synthetic Absorbable Surgical Suture Material
CAUTION: Federal (USA) law restricts this device to sale and u by, or on the order of, a physician. This device was designed, tested and manufactured for single patient u only. Reu or reprocessing of this device may lead to its failure and subquent patient injury. Reprocessing and/or resterilization of this device may create the risk of contamination and patient infection. Do not reu, reprocess or resterilize this device.
家长学校授课教案The Quill TM Knotless Tissue-Closure Device consists of barbed suture material, armed with a surgical needle on one end and a loop at the opposite end. The Quill™ Device is designed to anchor with a clod loop at one end and a uni-directional barbed ction on the other end. The Quill™ Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
The Quill™ Device is comprid of dyed (violet) polyester, poly(p-dioxanone). The empirical molecular f
ormula of which is (C4H6O3)X. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonantigenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
While the formation of barbs in the Quill™ Device reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the Quill™ Device can be compared to USP knot strength of non-barbed sutures. Additionally, USP designations for diameter are ud to describe the Quill™ Device suture material prior to barbing, except for minor variation in suture diameter with a maximum overage of 0.1 mm.
TENSILE STRENGTH
USP SUTURE SIZE SUTURE TENSILE
STRENGTH (kgf)
QUILL TM Device地暖和暖气片
EQUIVALENT SIZE
2-0 2.68 0
ACTIONS
Two important characteristics describe the in vivo performance of absorbable sutures: first, tensile strength retention and cond, the absorption rate (loss of mass). The Quill™ Device has been formulated to minimize the variability of the characteristics and to provide wound support through the critical wound healing period and an extended healing period.
The results of implantation studies in animals using Quill™ Device comprid of dyed PDO indicate that for sizes 3-0 and larger, approximately 80% of its original strength remains after two weeks and four weeks of implantation. At six weeks post implantation, approximately 40% to 70% of its original strength is retained.
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Data obtained from implantation studies show that absorption of Quill™ Device comprid of dyed PDO is minimal until about 120 days, and esntially complete within 180 days (six months).
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鸣人日雏田INDICATIONS
Quill™ Device comprid of dyed PDO is indicated for u in soft tissue approximation where u of
absorbable sutures is appropriate. CONTRAINDICATIONS
The Quill™ Device comprid of dyed PDO is not to be ud where prolonged (beyond six weeks) approximation of tissues under stress is required and is not to be ud in conjunction or for fixation of prosthetic devices (e.g. heart valves or synthetic grafts) that are non-absorbable in nature.
WARNINGS
The loop of the Quill™ Device for wound closure should be deployed by urs familiar with surgical procedure, techniques and tissues. Physicians should consider the quantity and quality of tissue in which the loop will be anchored. The u of this suture may be inappropriate in highly vascularized tissue or fragile tissue that cannot withstand potential further tightening/constriction within the loop.
Urs should be familiar with surgical procedure and techniques involving absorbable sutures before employing Quill™ Device comprid of PDO for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material ud. Physicians should consider the in vivo performance (under ACTIONS ction) when lecting a suture for u in patients. The u of this suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing.
As with any foreign body, prolonged contact of any suture with salt solutions, such as tho found in the urinary or biliary tracts may result in calculus formation. As an absorbable suture, PDO may act transiently as a foreign body. Acceptable surgical practice should be followed for the management of contaminated or infected wounds.
As this is an absorbable suture material, the u of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention or which may require additional support.
The safety and effectiveness of Quill™ Device comprid of dyed PDO have not been established for u in fascial closures (including abdominal wall, thoracic and extremity fascial closures), gastrointestinal anastomos, cardiovascular tissue, neural tissue, ophthalmic surgery or for u in microsurgery. Under certain circumstances, notably orthopedic procedures, immobilization by external support may be employed at the discretion of the surgeon.动物的英语怎么说
PRECAUTIONS
The Quill™ Device contains a loop end and barbs to anchor tissues and does not require knots to approximate opposing edges of a wound. Tying of knots on the barbed ction of the material will d
amage the barbs and potentially reduce their effectiveness. For the device to function properly, Quill™ Device must first be anchored in the tissue by the deployment of the loop around robust tissue, then with the other subquently engaged in the tissue by the barbs. Additionally, when completing placement of the barbed gment, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the Quill™ Device in place.
Avoid contacting the Quill™ Device with other materials (e.g. surgical gauze, drapes, etc.) in the surgical field to prevent ensnaring on the barbs. If the barbs catch, carefully pull the material in the opposite direction of the straight needle to dingage it from the barbs.
When using the Quill™ Device subcutaneously, the device should be placed as deeply as possible in order to minimize erythema and induration normally associated with absorption.
Care should be taken to avoid damage when handling. Avoid crushing or crimping the suture material with surgical instruments, such as needle holders and forceps. Do not attempt to remove memory in the polymer by running fingers down the suture material as this can damage the barbs.
Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances wound dehiscence are typical or foreeable risks associated with any suture and hence are also po
tential complications associated with Quill TM Device.
Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.
Reshaping needles may cau them to lo strength and be less resistant to bending and breaking. Urs should exerci caution when handling surgical needles to avoid inadvertent needle sticks. Discard ud needles in designated biohazard “sharps” containers.
ADVERSE REACTIONS
Adver effects associated with the u of this device may include, wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions occurs and transitory local infection as the wound site. Broken needles may result in extended or additional surgeries or residua
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l foreign bodies. Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens.
Due to prolonged suture absorption, some irritation and bleeding may occur. APPLICATION
U as required per surgical procedure. Secure nonbarbed loop portion to a robust tissue. Start by taking a bite of the designated anchoring tissue and then pass the needle through the loop and pull in order tighten loop around entrapped tissue. Once the Quill™ Device is anchored into the tissue, take at least two loo bites of this tissue to be approximated. Once at least two bites, or pass through the tissue have been completed, the strand can then be grasped and the tissue can be approximated to the desired tension. Bites, or pass through the tissue, can be taken in a continuous suturing technique to approximate the wound. Care should be taken to utilize the Quill™ Device on the barbed gments only. Do not attempt to approximate wounds using the non-barbed gments, as the barbs are required for successful wound approximation with the Quill™ Device.
To remove the entire Quill TM Device: Cut the Quill TM Device at the end anchored with the loop, and then pull the distal end to remove the device.
STERILITY
The Quill™ Device comprid dyed PDO is sterilized by ethylene oxide gas. Do not resterilize. Do not u if package is opened or damaged. Discard opened unud sutures. Do not u after expiration date.
梦见拾钱HOW SUPPLIED
The Quill™ Device comprid of dyed PDO is available sterile, dyed violet in various lengths and with a USP diameter size 0 (metric size 0.35). Each Quill TM Device is single armed with various needle sizes.
